[Federal Register Volume 74, Number 33 (Friday, February 20, 2009)]
[Notices]
[Page 7908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-3554]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0044]


Draft Guidance for Industry on Influenza: Developing Drugs for 
Treatment and/or Prophylaxis; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Influenza: 
Developing Drugs for Treatment and/or Prophylaxis.'' Recent concerns 
about the possibility of pandemic spread of novel influenza strains 
have increased interest in influenza drug development for both seasonal 
and pandemic settings. The purpose of this guidance is to assist 
sponsors in all phases of influenza drug development and to address 
questions FDA often receives regarding the potential for emergency use 
of influenza drugs for the treatment and/or prophylaxis of influenza.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by May 21, 2009.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. Submit written comments on the draft guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://www.regulations.gov. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: Debra Birnkrant, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6332, Silver Spring, MD 20993-0002, 301-
796-0770.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Influenza: Developing Drugs for Treatment and/or 
Prophylaxis.'' Because of the public health implications of both 
seasonal and pandemic influenza, the variable nature of the disease, 
and the limited therapeutic options and challenges in studying new 
options, FDA is developing guidance to assist sponsors in all phases of 
influenza drug development. This draft guidance addresses preclinical 
development, early phases of clinical development, phase 3 protocol 
designs and endpoints for the treatment of both uncomplicated and 
serious influenza, and protocol designs for the prophylaxis of 
symptomatic influenza. This guidance also addresses the role of animal 
data in an influenza drug development program and considerations 
relating to the potential for emergency use of influenza drugs 
including advance development of protocols for further exploration and 
verification of drug effects.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on developing 
drugs for the treatment and/or prophylaxis of influenza. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statutes and 
regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 312 and 314 have 
been approved under OMB Control Numbers 0910-0014 and 0910-0001, 
respectively.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
eitherhttp://www.fda.gov/cder/guidance/index.htm or http://www.regulations.gov.

    Dated: February 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-3554 Filed 2-19-09; 8:45 am]
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